MAV · Class II · 21 CFR 870.1650

FDA Product Code MAV: Syringe, Balloon Inflation

Leading manufacturers include Merit Medical Systems, Inc., Boston Scientific Corp and Advanced Cardiovascular Systems, Inc..

58
Total
58
Cleared
123d
Avg days
1981
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 241d recently vs 120d historically

FDA 510(k) Cleared Syringe, Balloon Inflation Devices (Product Code MAV)

58 devices
1–24 of 58
Cleared Sep 04, 2026
Digital Indeflator INFLANTE
K260035
UAB Telemedicina
Cardiovascular · 241d
Cleared Apr 13, 2022
Everest 20 Inflation Device and 3-way Stopcock (AC2200)
K220773
Medtronic Vascular
Cardiovascular · 28d
Cleared Oct 20, 2016
Fluent inflation device
K162272
Vascular Solutions, Inc.
Cardiovascular · 69d
Cleared Apr 13, 2016
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
K153038
Medtronic, Inc.
Cardiovascular · 177d
Cleared Jan 20, 2016
basixTOUCH40 Inflation Syringe
K153672
Merit Medical Systems, Inc.
Cardiovascular · 30d
Cleared Dec 18, 2015
Fluent Inflation Device
K152387
Vascular Solutions, Inc.
Cardiovascular · 116d
Cleared Mar 05, 2015
MASTRO PLUS BALLOON IN-DEFLATION DEVICE
K140943
Beijing Demax Medical Technology Co.,Ltd
Cardiovascular · 325d
Cleared Jan 12, 2015
Presto Inflation Device
K143522
C.R. Bard, Inc.
Cardiovascular · 31d
Cleared Dec 12, 2014
SUMMED INFLATION DEVICE KIT
K133795
Sunny Medical Device (Shenzhen) Co., Ltd.
Cardiovascular · 364d
Cleared Apr 17, 2014
ENCORE 26 ADVANTAGE KIT
K140745
Boston Scientific Corp
Cardiovascular · 23d
Cleared Jun 19, 2013
BASIXTOUCH
K130566
Merit Medical Systems, Inc.
Cardiovascular · 107d
Cleared Dec 19, 2012
BASIXCONPAK ANALOG INFLATION SYRINGE
K122321
Merit Medical Ireland, Ltd.
Cardiovascular · 140d
Cleared Dec 14, 2012
OXTI INFLATION DEVICE
K122152
Oxti Corporation
Cardiovascular · 147d
Cleared Nov 13, 2012
ENCORE 26 ADVANTAGE KIT
K123214
Boston Scientific Corp
Cardiovascular · 29d
Cleared Apr 03, 2012
ENCORE 26 ADVANTAGE KIT
K120694
Boston Scientific Corp
Cardiovascular · 27d
Cleared Jul 01, 2011
ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK
K102648
Shenzhen Ant Hi-Tech Industrial Co., Ltd.
Cardiovascular · 290d
Cleared Dec 15, 2008
SEDAT FLAMINGO
K082755
Sedat
Cardiovascular · 87d
Cleared Jul 12, 2006
QL LOCKING SYRINGE
K060643
Atrion Medical Products, Inc.
Cardiovascular · 124d
Cleared Apr 18, 2005
DOLPHIN INFLATION DEVICE
K042449
Sedat S.A.
Cardiovascular · 221d
Cleared Feb 13, 2004
VICEROY INFLATION DEVICE
K040138
Merit Medical Systems, Inc.
Cardiovascular · 22d
Cleared Jan 22, 2002
VANGUARD REPROCESSED INFLATION DEVICES
K012480
Vanguard Medical Concepts, Inc.
Cardiovascular · 173d
Cleared Oct 25, 1999
INTELLISYSTEM II COLOR MONITOR
K993341
Merit Medical Systems, Inc.
Cardiovascular · 20d
Cleared Sep 12, 1996
INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)
K962495
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 78d
Cleared May 30, 1996
MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT
K960983
Medtronics Interventional Vascular
Cardiovascular · 80d

About Product Code MAV - Regulatory Context

510(k) Submission Activity

58 total 510(k) submissions under product code MAV since 1981, with 58 receiving FDA clearance (average review time: 123 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MAV Product Code

Recent submissions under MAV have taken an average of 241 days to reach a decision - up from 120 days historically. Manufacturers should account for longer review timelines in current project planning.

MAV devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →